A Formative Evaluation of a Trial for OEF/OIF Veterans with Chronic Pain Abstract Background: Pain is a pervasive health problem among veterans, including OEF/OIF (Operation Enduring Freedom/Operation Iraqi Freedom) veterans, but there is a paucity of research on how to best treat pain in this group of veterans. Currently underway is the VA RR&D funded ESCAPE (Evaluation of Stepped Care for Chronic Pain) intervention, a stepped- care intervention for OEF/OIF veterans with chronic pain. This trial will provide quantitative data to assess the overall effectiveness of a complex pain intervention. However, ESCAPE was not designed to determine which components of the ESCAPE trial are effective (or ineffective) for pain management and why patients believe them to be so. Objective: This pilot study will be a formative evaluation ESCAPE. While ESCAPE was designed to assess the overall effectiveness of a complex, stepped care pain intervention, it was not designed to determine 1) which individual components of the trial (i.e., optimization of analgesics, self-management, cognitive behavioral therapy, patient-provider communication) are perceived by veterans to be most or least helpful;or 2) how veterans who demonstrate a clinically meaningful response to the intervention may differ from those who did not respond. These detailed data of veterans'own perceptions and experiences of ESCAPE, including what worked and did not work for them, are critical for the design of a subsequent intervention for OEF/OIF veterans with chronic pain that builds upon the strengths of ESCAPE and improves upon its deficiencies as identified by veterans. Methods: We will conduct in-depth interviews with 30 veterans who have completed the ESCAPE intervention. Sampling will be purposeful in order to include veterans from 3 specific groups of interest: 1) veterans who demonstrated a clinically meaningful response to the trial (defined as a 30% reduction in pain symptoms);2) veterans who did not respond to the trial; and 3) veterans who adhered to less than 50% of the trial. Interview questions will relate to veterans'experiences with the individual components of the intervention, their overall perceptions of the interventions, strengths of the trial, suggestions for improvement, and veterans'views of the communication they experienced with their care providers during the trial. After conducting an emergent thematic analysis, we will then compare veterans'perceptions of the intervention to determine if these perceptions differed based upon their clinical response or adherence to the intervention. The data from this formative evaluation, coupled with ESCAPE's quantitative data, will allow us to employ elements of ESCAPE that veterans found helpful, reevaluate and modify elements that veterans found unhelpful, and work to maximize patient retention and adherence in the next trial. Data from this formative evaluation are crucial to improve care for OEF/OIF veterans who continue to come home with debilitating and painful injuries.